Clinical Trials/NCT00960661

NCT00960661

Completed

Phase 3

A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

AstraZeneca1 site in 1 country1,036 target enrollmentSeptember 2009

ConditionsType 2 Diabetes Mellitus

Interventionsexenatide Metformin Insulin/ Glargine insulin lispro

Drugsexenatide insulin lispro Metformin Insulin/ Glargine

Overview

Phase: Phase 3
Intervention: exenatide
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 1036
Locations: 1
Primary Endpoint: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

August 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
•Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
•Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
•Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
•Have an HbA1C \> 7.0% and ≤ 10.0%.
•Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.

Exclusion Criteria

•Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
•Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
•Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
•Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
•Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
•Have previously completed or been withdrawn from this study after enrollment.

Arms & Interventions

Exenatide (BET)

Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)

Intervention: exenatide

Exenatide (BET)

Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)

Intervention: Metformin

Exenatide (BET)

Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)

Intervention: Insulin/ Glargine

Insulin Lispro (BBT)

Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)

Intervention: insulin lispro

Insulin Lispro (BBT)

Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)

Intervention: Metformin

Insulin Lispro (BBT)

Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)

Intervention: Insulin/ Glargine

Outcomes

Primary Outcomes

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30

Time Frame: Baseline, 30 weeks

Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).

Secondary Outcomes

Percentage of Participants Achieving HbA1C < 7.0%(Week 30)
Percent of Participants Achieving HbA1c ≤ 6.5%.(Week 30)
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.(Baseline, Week 30)
Change in Total Cholesterol From Baseline to Week 30(Baseline, week 30)
Change in High Density Lipoprotein (HDL) From Baseline to Week 30(Baseline, week 30)
Change in Low Density Lipoprotein (LDL) From Baseline to Week 30(Baseline, Week 30)
Change in Body Weight From Baseline to Week 30.(baseline, week 30)
Change in Systolic Blood Pressure (SBP) From Baseline to Week 30(Baseline, Week 30)
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30(baseline, Week 30)
Daily Insulin Glargine Dose at Baseline and at Week 30(Baseline, week 30)
Major Hypoglycemia Rate Per Year(30 weeks)
Minor Hypoglycemia Rate Per Year(30 weeks)